Standard
In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.
According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.
In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.
International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.
Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.
- Structure:
- Chemical Name:Cefodizime oxidation Impurity 1
- CAS:111874-11-4
- MF:C20H20N6O7S4
- Chemical Name:Spectinomycin Impurity F
- CAS:
- MF:
- Structure:
- Chemical Name:(7S,8R)-3-[2-(tert-butylamino)acetamido]-7-[[4-carbamoyl-2-(dimethylamino)-3,5,6-trihydroxyphenyl]methyl]-6-carboxy-5,8-dihydroxy-N,N-dimethyl-4-oxo-7,8-dihydronaphthalen-1(4H)-iminium
- CAS:
- MF:C29H38N5O10+
- Structure:
- Chemical Name:3-pentylisobenzofuran-1(3H)-one
- CAS:111943-62-5
- MF:C13H16O2
- Structure:
- Chemical Name:2-[[2-2(2-Amino-4-thiazolyl)acetyl]amino]-4-thiazoleacetic Acid
- CAS:2036283-13-1
- MF:C10H10N4O3S2
- Structure:
- Chemical Name:Levofloxacin Impurity 18
- CAS:138998-47-7
- MF:C14H13F4NO3
- Structure:
- Chemical Name:N-(2-methyl-5-(methylamino)phenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide
- CAS:
- MF:C18H17N5O
- Structure:
- Chemical Name:methyl3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin -4-yl)amino)piperidin-1-yl)-3-oxopropanoate
- CAS:1616761-01-3
- MF:C17H23N5O3
- Chemical Name:Labetalol iMpurity
- CAS:2731858-23-2
- MF:
- Chemical Name:ZXANKCFSGFEBQW-PFEQFJNWSA-N
- CAS:1258938-54-3
- MF:
- Structure:
- Chemical Name:TWEORVZIMOFLDE-MXTNKPTQSA-N
- CAS:1706671-50-2
- MF:C25H31N5O9S
- Structure:
- Chemical Name:WGEFOIHAXGTXJE-RTMVWDMESA-N
- CAS:1373171-12-0
- MF:C48H61NO14
- Structure:
- Chemical Name:ZIMIAPVHHUISPY-CLFYSBASSA-N
- CAS:866954-86-1
- MF:C15H15F3O5
- Structure:
- Chemical Name:2-Propanone, 1,3-bis(4-methoxyphenyl)-
- CAS:29903-09-1
- MF:C17H18O3
- Structure:
- Chemical Name:1,3-bis(2-chloroethyl)benzimidazolin-2-one
- CAS:55470-74-1
- MF:C11H12Cl2N2O
- Chemical Name:Nintedanib Impurity A (Intedanib Impurity A )
- CAS:
- MF:
- Structure:
- Chemical Name:1-[(4-Ethoxy-3-formylphenyl)sulfonyl]-4-methylpiperazine
- CAS:332374-42-2
- MF:C14H20N2O4S
- Structure:
- Chemical Name:ApovincaMinic Acid Ethyl Ester N-Oxide
- CAS:109741-24-4
- MF:C22H26N2O3
- Chemical Name:Afatinib Impurity M
- CAS:
- MF:
- Structure:
- Chemical Name:Ornidazole Impurity
- CAS:1100750-18-2
- MF:
- Structure:
- Chemical Name:4-(3-nitrophenyl)-3-Morpholinone
- CAS:845729-43-3
- MF:C10H10N2O4
- Structure:
- Chemical Name:PDXA-226
- CAS:352637-51-5
- MF:C14H14N2O
- Structure:
- Chemical Name:Ropivacaine-ET-R
- CAS:98626-60-9
- MF:C16H24N2O
- Structure:
- Chemical Name:Ropivacaine-iPr-S
- CAS:265120-58-9
- MF:C17H26N2O
- Structure:
- Chemical Name:(S)-N,N-dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine
- CAS:1384080-33-4
- MF:C19H21NOS
- Structure:
- Chemical Name:methyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate
- CAS:
- MF:C17H15NO4S
- Chemical Name:Apremilast impurity 15
- CAS:
- MF:
- Structure:
- Chemical Name:Aprepitant Impurity 22
- CAS:934540-48-4
- MF:C20H16F7NO2
- Structure:
- Chemical Name:Aprepitant Impurity 9
- CAS:219821-37-1
- MF:C24H25F7N4O4
- Structure:
- Chemical Name:Betamethasone EP Impurity I
- CAS:185613-69-8
- MF:C22H29FO5
- Structure:
- Chemical Name:Canagliflozin Impurity 14
- CAS:842133-17-9
- MF:C24H25FO5S
- Chemical Name:Carfilzomib Impurity F
- CAS:
- MF:
- Structure:
- Chemical Name:Cefamandole Impurity A
- CAS:1947364-12-6
- MF:C17H16N2O6S
- Structure:
- Chemical Name:Dapagliflozin Impurity 19
- CAS:1469910-84-6
- MF:C29H33ClO10
- Chemical Name:Docetaxel EP Impurity A
- CAS:
- MF:
- Chemical Name:Empagliflozin Impurity 21
- CAS:
- MF:
- Chemical Name:Febuxostat Impurity 43
- CAS:
- MF:
- Chemical Name:Formoterol Impurity 20
- CAS:
- MF:
- Chemical Name:Hydroxychloroquine Impurity 2
- CAS:
- MF:
- Structure:
- Chemical Name:Ibrutinib Impurity 14
- CAS:2417548-76-4
- MF:C50H48N12O4
- Chemical Name:Imatinib impurity 11
- CAS:
- MF:
- Structure:
- Chemical Name:Isavuconazole Impurity 2
- CAS:2001051-99-4
- MF:C13H12F2N4O
- Chemical Name:Isavuconazole Impurity 25
- CAS:
- MF:
- Structure:
- Chemical Name:Loxoprofen Impurity 18
- CAS:99807-54-2
- MF:C11H13BrO2
- Structure:
- Chemical Name:Mupirocin EP Impurity D
- CAS:71087-97-3
- MF:C26H44O9
- Structure:
- Chemical Name:N-Acetyl-Lys-Octreotide
- CAS:173606-11-6
- MF:C51H68N10O11S2
- Chemical Name:Olaparib Impurity 3
- CAS:
- MF:
- Structure:
- Chemical Name:Posaconazole Impurity 33
- CAS:182210-71-5
- MF:C12H13F2IO2
- Chemical Name:Posaconazole Impurity 38
- CAS:
- MF:
- Chemical Name:Posaconazole Impurity 62
- CAS:
- MF:
- Chemical Name:Roxithromycin Impurity J
- CAS:
- MF:
- Structure:
- Chemical Name:Sitagliptin Impurity 21
- CAS:2088771-60-0
- MF:C20H19F6N5O5
- Chemical Name:SofosBuvir Impurity 38
- CAS:
- MF:
- Structure:
- Chemical Name:1-(4-AMinophenyl)-5,6-dihydro-3-(4-Morpholinyl)-2(1h)-pyridinone
- CAS:1267610-26-3
- MF:C15H19N3O2
- Structure:
- Chemical Name:Erlotinib IMpurity C
- CAS:1312937-41-9
- MF:C15H20N2O5
- Structure:
- Chemical Name:Cinacalcet IMpurity
- CAS:1229224-93-4
- MF:C22H26F3N
- Structure:
- Chemical Name:SalMeterol iMpurity
- CAS:144391-74-2
- MF:C25H37NO4
- Chemical Name:AzithroMycin iMpurity R
- CAS:
- MF:
- Chemical Name:ceftazidiMe iMpurity E
- CAS:
- MF:
- Structure:
- Chemical Name:CefuroxiMe Axetil iMpurity C
- CAS:76598-06-6
- MF:C18H15Cl3N4O9S
- Chemical Name:Rupatadine iMpurity D
- CAS:
- MF:
- Structure:
- Chemical Name:2-[1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyriMidine-4,5,6-triaMine
- CAS:428854-24-4
- MF:C17H15FN8
- Structure:
- Chemical Name:AR-C 124910XX
- CAS:220347-05-7
- MF:C21H24F2N6O3S
- Structure:
- Chemical Name:Doxazosin iMpurity
- CAS:1219803-95-8
- MF:C23H26ClN5O5
- Chemical Name:Montelukast iMpurity
- CAS:
- MF:
- Structure:
- Chemical Name:Vildagliptin iMpurity A-F
- CAS:1846606-32-3
- MF:C7H10N2O3
- Structure:
- Chemical Name:NM-2201
- CAS:837112-21-7
- MF:C24H22FNO2
- Structure:
- Chemical Name:5a-17-(3-Pyridyl)-16-androstene-3-one
- CAS:
- MF:C24H31NO
- Chemical Name:AMpicillin EP IMpurity E
- CAS:
- MF:
- Chemical Name:AtracuriuM IMpurity H (Mixture of cis, trans(H1), cis, cis(H2) tans, trans IsoMer)
- CAS:1248429-33-5
- MF:
- Chemical Name:Ceftriaxone IMpurit B
- CAS:
- MF:
- Chemical Name:Flucloxacillin IMpurity F
- CAS:
- MF:
- Structure:
- Chemical Name:IMidafenacin IMpurity (1-(3-Cyano-3,3-Diphenylpropyl)-2-Methyl-1H-IMidazoliuM Phosphate)
- CAS:562091-56-9
- MF:C20H22N3O4P
- Structure:
- Chemical Name:Lercanidipine IMpurity B
- CAS:1119226-97-9
- MF:C35 H37 N3 O6
- Structure:
- Chemical Name:Milrinone IMpurity 2
- CAS:400063-10-7
- MF:C12H7N3O2
- Structure:
- Chemical Name:Moxifloxacin Decarboxy Analog
- CAS:1322062-57-6
- MF:C20H24FN3O2
- Structure:
- Chemical Name:Naratriptan IMpurity E
- CAS:1346746-73-3
- MF:C20H32N4O4S2
- Structure:
- Chemical Name:PraMipexole DiMer IMpurity II
- CAS:2206826-82-4
- MF:C20H32N6S2
- Structure:
- Chemical Name:Rosuvastatin Substituted Hydroxy Pentenoic Acid
- CAS:910867-11-7
- MF:C20H24FN3O5S
- Structure:
- Chemical Name:EthanediaMide iMpurity k
- CAS:2803419-58-9
- MF:C2H4N2O2
- Structure:
- Chemical Name:(1S,2S,3R,5S)-3-(7-hydroxy-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
- CAS:1445580-43-7
- MF:C14H21N5O5S
- Structure:
- Chemical Name:D-threo-Pentitol, 2,5-anhydro-1,3,4-trideoxy-2-C-(2,4-difluorophenyl)-4-(hydroxyMethyl)-1-(1H-1,2,4-triazol-1-yl)-
- CAS:160709-02-4
- MF:C14H15F2N3O2
- Structure:
- Chemical Name:Bivalirudin iMpurity
- CAS:72378-50-8
- MF:C6H8N2O4
- Structure:
- Chemical Name:2-(4-tert-Butyl-3-hydroxy-2,6-dimethylphenyl)acetic acid
- CAS:55699-12-2
- MF:C14H20O3
- Structure:
- Chemical Name:(S)-Fesoterodine FuMarate
- CAS:1431511-18-0
- MF:C30H41NO7
- Structure:
- Chemical Name:(3S)-10-(4-Ethyl-1-piperazinyl)-9-fluoro-2,3-dihydro-3-Methyl-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid (Levofloxacin IMpurity)
- CAS:106939-30-4
- MF:C19H22FN3O4
- Structure:
- Chemical Name:(6S,12bR)-6-(1,3-Benzodioxol-5-yl)-2,3,7,12b-tetrahydro-2-Methyl-pyrazino[1',2':1,5]pyrrolo[3,4-b]quinoline-1,4,12(6H)-trione
- CAS:531500-48-8
- MF:C22H17N3O5
- Chemical Name:SofosBuvir Impurity 61
- CAS:
- MF:
- Structure:
- Chemical Name:Suvorexant Impurity 2
- CAS:1276666-19-3
- MF:C23H23ClN6O2
- Chemical Name:Tenofovir impurity L
- CAS:
- MF:
- Structure:
- Chemical Name:Ticagrelor Impurity 27
- CAS:1402150-01-9
- MF:C19H26ClN5O5S
- Chemical Name:Ticagrelor impurity P
- CAS:
- MF:
- Structure:
- Chemical Name:Tramadol Impurity 1
- CAS:66170-32-9
- MF:C16H25NO2
- Structure:
- Chemical Name:Lidocaine EP Impurity G
- CAS:42459-30-3
- MF:C13H20N2O
- Structure:
- Chemical Name:methyl 1,4-dihydroxy-7-phenoxyisoquinoline-3-carboxylate
- CAS:1421312-32-4
- MF:C17H13NO5
- Structure:
- Chemical Name:1-(2,3-DIMETHYLPHENYL)PROPAN-1-OL
- CAS:944268-64-8
- MF:C11H16O
- Structure:
- Chemical Name:4-(4-chlorophenyl)-5-methyl-3-phenylisoxazole
- CAS:1448355-87-0
- MF:C16H12ClNO